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CONSUMER INC.
Skillman, NJ 08558
Neutrogena Adapalene 0.1% Acne Treatment Gel
FDA Label NDC 69968-0826
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Neutrogena Adapalene 0.1% Acne Treatment (NDC 69968-0826). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, warnings, otc - do not use, otc - pregnancy or breast feeding, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Adapalene, USP 0.1% (retinoid)*
*read consumer information leaflet
Purpose
Acne treatment
Use
For the treatment of acne
Warnings
For external use only
Otc - Do Not Use
Do not use
▪on damaged skin (cuts, abrasions, eczema, sunburn)
▪ if you are allergic to adapalene or any of the ingredients in this product
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a doctor before use.
Otc - When Using
When using this product
▪ limit sun exposure, including light from tanning beds, and use sunscreen when going outdoors.
▪ do not wax to remove hair in areas where the product has been applied
▪ during the early weeks of use, your acne may appear to worsen before it improves (this is normal); continue using as directed, unless you get irritation that becomes severe
▪ irritation (redness, itching, dryness, burning) is more likely to occur:
▪ in the first few weeks of use
▪ if using more than one topical acne medication at a time
▪ but irritation usually lessens with continued use of this product
▪ it may take up to 3 months of once daily use to see results
▪ avoid product contact with the eyes, lips, and mouth. If contact occurs, immediately flush the area with water.
▪ wash hands after use
Otc - Stop Use
Stop use and ask a doctor if
▪ you become pregnant, or are planning to become pregnant while using the product
▪ you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath)
▪ irritation becomes severe
▪ you see no improvement after 3 months of once daily use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Directions
Adults and children 12 years of age and older:
▪ use once daily
▪ clean the skin gently and pat dry before applying the product
▪ cover the entire affected area with a thin layer. For example, if your acne is on the face, apply the product to the entire face.
▪ do not use more than one time a day. Applying more than directed will not provide faster or better results, but may worsen skin irritation.
Children under 12 years of age: ask a doctor
Other Information
▪ store at room temperature 68° to 77°F
▪ protect from freezing
Inactive Ingredients
carbomer homopolymer type C, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water
May contain hydrochloric acid and/or sodium hydroxide to adjust pH.
Questions Or Comments?
Call 800-582-4048; Outside US, dial collect
215-273-8755 or visit www.neutrogena.com
Principal Display Panel - 45 G Tube Carton
Neutrogena ®
DERMATOLOGIST RECOMMENDED BRAND
NEW
Adapalene
Gel 0.1%
Acne Treatment
Previously available only
By prescription
Dermatologist developed
& tested
Once Daily Topical
Retinoid*
Oil Free
Fragrance Free
*Read consumer information
leaflet before use
NET WT 1.6 OZ (45 g)
Neutrogena_01 (Neutrogena 01)
* Please review the disclaimer below.
